Results from the PHOTON study show that intravitreal aflibercept 8 mg is effective in treating diabetic macular edema over 48 weeks in a randomized, double-masked trial.
In the field of ophthalmology, particularly in the treatment of diabetic macular oedema (DMO), the use of intravitreal aflibercept has shown promising results in a recent study titled "Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial." The study aimed to evaluate the efficacy and safety of aflibercept 8 mg compared to the standard treatment of aflibercept 2 mg in patients with DMO.
The PHOTON trial was conducted across 138 hospitals and specialty retina clinics in seven countries, enrolling 660 patients with type 1 or 2 diabetes and DMO. Patients were randomly assigned to receive aflibercept 8 mg every 12 weeks, 8 mg every 16 weeks, or 2 mg every 8 weeks after an initial monthly dosing phase. The primary endpoint was the change from baseline in best-corrected visual acuity (BCVA) at week 48, with non-inferiority margin set at 4 letters.
Results showed that both aflibercept 8 mg dosing regimens (8q12 and 8q16) demonstrated non-inferior gains in BCVA compared to the standard aflibercept 2 mg regimen. The mean change from baseline in BCVA at week 48 was 8.8 letters in the 8q12 group, 7.9 letters in the 8q16 group, and 9.2 letters in the 2q8 group. The proportion of patients with ocular adverse events was similar across the treatment groups, with no new safety signals identified with aflibercept 8 mg.
Furthermore, the study explored additional secondary and exploratory endpoints, including changes in central retinal thickness (CRT) and diabetic retinopathy severity scale (DRSS) scores. Aflibercept 8 mg maintained extended dosing intervals in the majority of patients, with approximately 90% completing the 48-week treatment period without the need for interval shortening.
The findings suggest that aflibercept 8 mg could offer an effective and safe treatment option for DMO, potentially reducing treatment burden for patients by requiring fewer injections while providing similar visual acuity gains to aflibercept 2 mg. The study was well-designed, with strict adherence to protocol and thorough analysis of efficacy and safety outcomes.
In conclusion, the PHOTON trial results support the use of aflibercept 8 mg as a viable treatment option for patients with DMO, offering the potential for improved disease control and reduced treatment frequency. This research represents a significant advancement in the field of ophthalmology and may lead to improved outcomes for individuals with DMO.
Source:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02577-1/fulltext
The PHOTON trial was conducted across 138 hospitals and specialty retina clinics in seven countries, enrolling 660 patients with type 1 or 2 diabetes and DMO. Patients were randomly assigned to receive aflibercept 8 mg every 12 weeks, 8 mg every 16 weeks, or 2 mg every 8 weeks after an initial monthly dosing phase. The primary endpoint was the change from baseline in best-corrected visual acuity (BCVA) at week 48, with non-inferiority margin set at 4 letters.
Results showed that both aflibercept 8 mg dosing regimens (8q12 and 8q16) demonstrated non-inferior gains in BCVA compared to the standard aflibercept 2 mg regimen. The mean change from baseline in BCVA at week 48 was 8.8 letters in the 8q12 group, 7.9 letters in the 8q16 group, and 9.2 letters in the 2q8 group. The proportion of patients with ocular adverse events was similar across the treatment groups, with no new safety signals identified with aflibercept 8 mg.
Furthermore, the study explored additional secondary and exploratory endpoints, including changes in central retinal thickness (CRT) and diabetic retinopathy severity scale (DRSS) scores. Aflibercept 8 mg maintained extended dosing intervals in the majority of patients, with approximately 90% completing the 48-week treatment period without the need for interval shortening.
The findings suggest that aflibercept 8 mg could offer an effective and safe treatment option for DMO, potentially reducing treatment burden for patients by requiring fewer injections while providing similar visual acuity gains to aflibercept 2 mg. The study was well-designed, with strict adherence to protocol and thorough analysis of efficacy and safety outcomes.
In conclusion, the PHOTON trial results support the use of aflibercept 8 mg as a viable treatment option for patients with DMO, offering the potential for improved disease control and reduced treatment frequency. This research represents a significant advancement in the field of ophthalmology and may lead to improved outcomes for individuals with DMO.
Source:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02577-1/fulltext
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